FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Workflow Box
K Number: K181572
·
Decision Jul 10, 2018
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
45
Applicant Total
8
Review Days
26
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Basic Information
- Device Name
- Workflow Box
- K Number
- K181572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mirada Medical, Ltd.
- Date Received
- June 14, 2018
- Decision Date
- July 10, 2018
- Product Code
- QKB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QKB | Radiological Image Processing Software For Radiation Therapy | FDA class 2 | Radiology |
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| K101228 | MIRADA XD | Jun 23, 2010 | Substantially Equivalent |